Protection of Rights of Knowledge Holders and Practitioners of Traditional Medicine in Tanzania

Background: Lack or inadequate implementation and enforcement of legal frameworks for accessing and benefit sharing arising from the use of traditional and indigenous knowledge is associated with sub-optimal exploitation of traditional medicine knowledge and related research outputs in many African countries. Objectives: This study assessed the practice of protecting the rights of holders of traditional medicine knowledge, and identified challenges in regulating, registering and protecting traditional medicine based services, processes and products in Tanzania. Methods: Practice of protecting the rights of holders of traditional medicine knowledge in Tanzania was assessed through interviews with 12 knowledge holders and practitioners of traditional medicines, and 12 key informants from national regulatory authorities, and research and high learning institutions involved in traditional medicine research and development in Tanzania. Results: Absence of frameworks for accessing and benefit sharing arising from the use of tradition medicine knowledge, mistrust and inadequate knowledge on procedures for protection of traditional medicine based intellectual property hampers the practice of protecting the rights of holders of traditional medicine knowledge in Tanzania. Costly and bureaucratic procedures are among the challenges encountered by knowledge holders and practitioners of tradition medicine in registration of their traditional medicine products and practices. Poor network relationship between holders of traditional medicine knowledge and research community slow down the progress of traditional medicine research and development. Lack of guidelines for regulation of traditional medicine research may be the result of overlapping roles of the National Institute for Medical Research and the Council of Traditional and Alternative Medicine Conclusion: In Tanzania, the environment for protecting the rights of holders of traditional medicine knowledge is suboptimal. To stimulate exploitation of traditional medicine for economic growth, there is a need to develop and implement national and institutional frameworks for accessing and benefit sharing arising from the use of traditional knowledge.


BACKGROUND
T he Swakopmund Protocol on the Protection of Traditional Knowledge (TK) and Expression of Folklore defines the term traditional knowledge as any knowledge originating from a local or traditional community that is the result of intellectual activity and insight in a traditional context, including knowhow, skills, innovations, practices and learning, where the knowledge is embodied in the traditional lifestyle of a community, or contained in the codified knowledge systems passed on from one generation to another 1 .Traditional knowledge is not limited to a specific technical field, and may include agricultural, environmental or medical knowledge, and knowledge associated with genetic resources. 1e protection of Traditional Knowledge and Traditional Cultural Expressions (TCEs) as an autonomous Intellectual Property Rights (IPRs) is now becoming a reality around the globe and particularly in the African Continent.Currently negotiations on an international legal instrument for the protection of TK are taking place within the World Intellectual Property Organization (WIPO), particularly in the WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore, in order to address the positive protection of TK. 2 The benefits derived from the legal protection of TK and TCEs necessitate the enactment of specific or incorporation of sufficient provisions within the existing legal framework.The international Intellectual Property Community has proposed for the adoption of the sui generis approach to the protection of TK and TCEs due to the challenges and inadequacy associated with the application of the existing Intellectual Property Rights.Some African countries have adopted the Swakopmund Protocol on the Protection of Traditional Knowledge and Expressions of Folklore. 1 It is administered under the auspices of the African Regional Intellectual Property Organisation (ARIPO).The Swakopmund Protocol on the Protection of Traditional Knowledge and Expressions of Folklore within the Framework of the African Regional Intellectual Property Organization (ARIPO) 1 was adopted on August 9, 2010, amended on December 6, 2016 and, revised and reprinted in 2019. 1 The Protocol so far has been signed by ten ARIPO members, namely: Botswana, Ghana, Kenya, Lesotho, Liberia, Mozambique, Rwanda, Namibia, Zambia and Zimbabwe.These countries have subsequently enacted local legislations in order to meet their obligations under the Protocol.Kenya, for instance, adopted the Traditional Knowledge and Cultural Expressions Act in 2016.Tanzania have not adopted the protocol, and hence risking Traditional Knowledge and Traditional Cultural Expressions to be exploited by third parties without consultation of, and benefit sharing with, the community from which the knowledge or expressions originate.
The current World Health Organization (WHO) Traditional Medicine Strategy 3 build upon the framework for action laid out in the first WHO Traditional Medicine Strategy, 4 the traditional medicine sections of the 2004 -2007 WHO Medicines Strategy 5 and the traditional medicine components of the 2008 -2013 WHO Medicines Strategy. 6It aims to support Member States in developing proactive policies and implementing action plans that will strengthen the role of traditional medicine (TM) in keeping populations healthy.The objectives of the strategy include 1) promote integration of TM within national health care systems, where feasible, by developing and implementing national TM policies and programmes, 2) promote the safety, efficacy and quality of TM by expanding the knowledge base, and providing guidance on regulatory and quality assurance standards, 3) increase the availability and affordability of TM, with an emphasis on access for poor populations and 4) promote therapeutically sound use of appropriate TM by practitioners and consumers.
Over the years, WHO regional office for Africa spearheaded the implementation of a regional strategy 2 endorsed by African Heads of State in Lusaka, Zambia to promote the role of traditional, complementary and alternative medicine in health systems in the African region.[9] In Tanzania, the existence of traditional medicine practitioners and protection of their rights to practice is well recognized to the extent that Traditional Medicine Research Unit at the University of Dar es Salaam was established in 1974, and later elevated to an Institute of Traditional Medicine (ITM) in 1991.In 1989, a unit of traditional medicine was established within the ministry of health.In response to the WHO African Regional Strategy to promote traditional medicine, 3 the Act which established the Council of Traditional and Alternative Medicine was passed in 2002. 10In the same year, the National Institute for Medical Research (NIMR) which is responsible for conducting, coordinating, promoting and regulating traditional medicine research in Tanzania, established the department of traditional medicine research.In 2021, this department was promoted to a centre, which is known as NIMR Mabibo Traditional Medicine Research Centre.The functions of this centre are two folds: 1) conduct traditional medicine research and 2) massive production and commercialization of efficacious traditional medicines.
At the Sokoine University of Agriculture (SUA) and the University of Dar es Salaam (UDSM), the departments of Botany, Chemistry, Marine Sciences and Microbiology are all routinely involved in teaching as well as researching in traditional medicine and natural products.Tanzania Medicines & Medical Devices Authority is charged with the responsibility of regulating and controlling medicines, medical devices, herbal drugs and diagnostics.Furthermore, the government have prioritized traditional medicine research in its HSSP V and aims to enable the availability of safe and sustainable alternative treatment offered in conjunction with formal health care. 11 realization of potential of high learning and research institutions, and holders of traditional knowledge to contribute to the economic growth, the Ministry of Education, Science and Technology developed guideline which explicitly describes the role of COSTECH in supporting holders of traditional medicine knowledge and research community to protect, commercialize or add value to the identified innovations, inventions and traditional knowledge practice and products. 12While the Council of Traditional and Alternative Medicine 10 register traditional medicine practices and products, COSTECH, provides support to holders of TK to protect and commercialize innovations and inventions arising from the use of traditional knowledge. 12However, the country does not have legislations or specific frameworks for legal protection of TK. 13 The main objective of this study was to assess the practice of protecting the rights of holders of traditional medicine knowledge, and identify challenges in regulating, registering and protecting traditional medicine based services, processes and products in Tanzania.

METHODS Study Design and Participants
A qualitative, descriptive, and exploratory study design was employed to assess practice of research institutions, universities, and quality assurance and regulatory institutions in protecting the rights of holders of traditional medicine knowledge, and challenges associated with protection of traditional medicine based intellectual property in Tanzania.
In total 24 key informants were purposeful selected from research and high learning institutions involved in traditional medicine research and development, regulatory authorities of traditional medicine, and traditional medicine association (Table 1).Through the registrar of the Traditional and Alternative Medicine Council, database of the registered practitioners of traditional medicine and owners of the registered traditional medicine or herbal products was accessed.The database of practitioners of the traditional medicine was stratified by sex, and from each stratum, 3 key informants were randomly selected.Out of 6 sampled practitioners of traditional medicine, three were residents of Morogoro, Singida, and Dodoma Regions respectively.The sampled practitioners of traditional medicines were contacted, and each was requested to provide three names of holders of traditional medicine knowledge in his/her community.From the list provided by each practitioner of traditional medicine, one knowledge holder was randomly sampled.
Knowledge holders of traditional medicine included individuals who knows a particular plant which treat a certain disease.Knowledge owner may not necessarily practice traditional medicine.Individuals who practice traditional medicine are known as practitioners of traditional medicine or traditional healers. 10

Data Collection
Two in-depth interview guides were used to conduct interviews, one was for holders and practitioners of traditional medicine, and the other one was for key informants from research and high learning institutions involved in traditional medicine research and development, and regulatory of traditional medicine in the country.The tools were designed to capture information on respect to and the rights of knowledge holders and practitioners of TM, network relationship between knowledge holders and practitioners of TM, and institutions responsible for TM research and regulation, existence and implementation of frameworks for accessing and benefit sharing following the use of traditional medicine knowledge (TMK).Face to face interviews were conducted using Kiswahili language.However, 10 key informants residing outside Dar es Salaam were subjected to telephone interviews, and they included key informants from TMDA, Tanzania Traditional and Alternative Medicine Council, Ministry of Health -Traditional Medicine Unit, SUA, 3 practitioners of traditional medicine residents of Morogoro, Singida, and Dodoma, 3 holders of traditional knowledge residents of Morogoro, Singida, and Dodoma respectively.

Data Analysis
Audios were first transcribed by two research assistants.Translation of the transcribed audios was done by the principal investigator of the study.A stepwise approach was used for a deductive thematic analysis of the interview transcripts.First, research questions were examined to generate a coding framework with several themes.Individual transcripts and codes representing participants' responses to the questions were exported to relevant themes and related key issues (Table 2) within the coding framework.The codes were excluded when they did not provide critical value to the study.The coded data were exported to Microsoft Word (Microsoft Corporation) for interpretative analysis and report generation.Although all key informants knew the importance of intellectual property rights, limited knowledge on what should be protected and what steps to be taken to protect intellectual property created through innovation in traditional medicine impacted negatively on the use of intellectual property system.Only two out of 12 (about 17%) of the interviewed traditional medicine practitioners reported to have used intellectual property system.

DISCUSSION
In line with findings of a recently published study, 14 holders and practitioners of traditional medicine recognize that the Council of Traditional and Alternative Medicine is the regulatory body for traditional medicine practice and products.However, majority of interviewed holders of traditional medicine knowledge demonstrated low awareness regarding the different regulatory, coordinating and promoting roles of various public institutions such as NIMR, ITM, UDSM, TMDA, BRELA and GCLA.
Research and development institutions in Tanzania have inadequate capacity to effectively engage in commercial or entrepreneurial activities; and the holders of traditional knowledge do not have capital resources for R&D and commercialization of their products or practices either. 12,13Despite the existence of the guideline document which describes the role of COSTECH in supporting knowledge holders of traditional medicine and research community, 12 none of the study participants was aware of such document.It is possible that the guideline document was not widely disseminated and not packaged in a user friendly format for different audiences.Low awareness on COSTECH's role in promoting protection and commercialization of traditional knowledge based IP is further complicated by limited knowledge and low use of IP system among traditional knowledge holders and research community. 13][17][18][19][20] In Tanzania, nearly 70% of people frequently access healthcare through traditional healers or vendors. 21,22f those, 15% of users of traditional medicines have chronic diseases, and many of them have poor biological understanding of those chronic diseases. 21The practice of traditional medicine is also accompanied with malpractice that puts the health of its clients at risk. 23,24Hence limited access to traditional medicine information or the presence of imperfect information among practitioners and regulators can easily cause non-adherence and poor implementation of regulations, respectively. 9It is therefore important to revisit some of the R&D Committee of the Council of Traditional and Alternative Medicine 10 and ensure that both practitioners and regulators have access to evidence based information generated by high quality traditional medicine research.Apart from improving efficiency in registering practices and products of traditional medicine, establishing a sub-committee of Traditional Medicine Research Review sub-committee of the National Health Research Review Committee may help to effectively regulate the conduction of traditional medicine research in the country.According to the Tanzania Traditional Medicine Act, 10 traditional and alternative medicine practice and products must be licensed.Our results revealed that holders and practitioners were not satisfied with the registration and licensing process.All interviewed knowledge holders and practitioners of traditional medicine complained of the high costs, and cumbersome and bureaucratic registration processes.Similar to the findings of another study, practitioners criticized the procedure and termed it as a barrier to development of the traditional medicine sub-sector in the country. 14e belief that registered herbal medicines are more trusted, and can be easily commercialized is in line with the findings of the study, which was conducted in Moshi, Tanzania, whereby traditional healers and herbal vendors expressed the importance that credibility plays in their business. 17e challenges reported in this study ranged from mistrust, limited knowledge on registration and protection procedures to poor network relationships between traditional knowledge holders, research community and regulators of practice and products of traditional medicine.
In Tanzania, there is neither a comprehensive legislation nor incorporation of some provisions, in any of the existing legislation, which offers protection of traditional knowledge.The protection of Traditional Knowledge and Traditional Cultural Expressions is essential for the benefit of the holders as well as for national development.Knowledge holders and other stakeholders of traditional medicine in Tanzania hardly use the existing IP system for protection of TK.The country should think of adopting sui generis approach for effective protection of TK.
Mistrust which lead to fear of disclosure, and poor network relationship between TK holders, regulators and research community impact negatively on the development of traditional medicine in the country.This challenge can partly be addressed by developing local or adopting and implementing international or regional frameworks for accessing and sharing the benefits arising from the use of traditional knowledge.

Strengths and Limitations of the Study
This study triangulated information from various sources such as research and academic institutions, regulatory bodies, holders of TMK and practitioners of TM.However, half of the interviewed practitioners of traditional medicine and holders of knowledge were from Dar es Salaam, and the remaining half were from Morogoro, Singida, and Dodoma.Due to cultural diversity and differences in social norms, the interviewed TMK holders and TM practitioners represented the Eastern and Central Zones of the country.Thus, their views may differ with the views of these from other five Zones of the country.In future, researchers should consider to include representatives from each region or Zone.

CONCLUSIONS
In the absence of formal mechanisms for accessing and sharing benefits arising from the use of traditional medicine knowledge, it will be difficult for regulators and research community to establish good network relationship with TK holders and to effectively protect their rights.To improve efficiency in registration of traditional medicine practice and products, the government should think of establishing one-stop centre.Social behavioral communication change interventions for TK holders and research community should be developed and implemented in order to increase use of IP system.Short and long term IP training may help to close IP knowledge gap among traditional knowledge holders and research community.Furthermore, an examination on how investments in social and behavioral change interventions for researchers, regulators, knowledge holders and practitioners is needed to find out how such investments might reduce mistrust and improve the registration efficiency, and increase use of IP system by research community and holders of traditional knowledge, and increase commercialization of traditional knowledge based innovations in Tanzania.
All interviews were audio recorded and then transcribed and translated into English.In addition, mandates and functions of institutions which are involved in regulation of TM practices and products, and conduction and regulation of TM research and development (R&D) were reviewed.Thus, the mandates and functions of Tanzania Commission of Science and Technology (COSTECH), Council of Traditional and Alternative Medicine, the National Institute for Medical Research (NIMR), Institute of Traditional Medicine (ITM), Tanzania Medicines and Medical Devices Authority (TMDA), Government Chemist Laboratory Agency (GCLA), Muhimbili University of Health and Allied Sciences (MUHAS), Sokoine University of Agriculture (SUA) and University of Dar es Salaam (DSM) were reviewed.
RESULTSOverlappingRoles of Different Institutions in Regulation of Traditional Medicine Practice and Research Council of Traditional and Alternative Medicine was established by Act 10 number 23 of 2002 and mandated to monitor, regulate, promote, and support the research development of traditional medicine.Subject to the provisions of the Patents Act, 1987, the Minister of Health through the Council of Traditional and Alternative Medicine may provide for matters related to patenting of traditional medicine inventions.In the performance of its functions, the Council of Traditional and Alternative (Respondent 1-Knowledge Holders and Practitioners of Traditional Medicine).
Waiver for ethical approval to conduct the interviews was granted by the Medical Research Coordinating Committee (Ref number NIMR/HQ/R.8a/VolII of 2022/122).Study participants signed informed consent prior to interview.

TABLE 1 :
Number of Key Informants Registration and protection of traditional medicine based intellectual property and rights of knowledge holdersAlmost all the interviewed holders of traditional medicine knowledge said that they needed to register their herbal medicine not because of the law requirements but

TABLE 2 :
Themes and Key Issues There is no need to re-research, because we [traditional medicine practitioners] conduct research before we seek registration for our herbal medicines.I do not depend on anyone to conduct research, I do it myself.The job of universities and research institutions is documentation and not going to the forests to look for medicinal plants.Government should make use of us; we are capable of treating diseases with herbal medicines" (Respondent 5-Knowledge Holders and Practitioners of "I have submitted my application to BRELA for to registration of my herbal medicines but to date I have not received any response.Yeah, there are many advantages of using intellectual property system, but the costs may not be affordable by most of holders of traditional medicine knowledge" (use to treat certain diseases, shows that we respect traditional medicine.We use the collected information to conduct scientific research to prove their claims" (Respondent 2-Research, Regulatory and Quality Assurance Institutions)."People in general have little respect for traditional medicine that is why even the price of herbs in the market is very low" (Respondent 10-Knowledge Holders and Practitioners of Traditional Medicine)."What I have come to realize is that those with responsibility of regulating and promoting traditional medicine take advantage of their positions by using our knowledge for their personal gains.I had submitted my herbal medicine for research to one of the public institutions, but when I raised the issue of contract, the doctor I was supposed to work with suddenly